NIH Clinical Research Studies

Protocol Number: 07-N-0165

Active Accrual, Protocols Recruiting New Patients

Title:
Suppression and Facilitation of the Motor Cortex by Stimulation of the Cerebellum in Patients with Dystonia and Healthy Controls
Number:
07-N-0165
Summary:
This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia.

Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study. All candidates are screened with a medical history. People with blepharospasm also have a physical examination and blepharospasm rating.

Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in two 4-hour sessions, separated by 1 to 7 days.

TMS

A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.

EMG

Surface EMG is done during TMS to measure the electrical activity of muscles. For this test, electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the face.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

PATIENTS:

- Age 18 years or older

- Normal findings in the medical history, physical and neurological examination, except for dystonia

HEALTHY CONTROLS:

- Age 18 years or older

- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems

EXCLUSION CRITERIA:

Any of the following will exclude patients and controls from the study:

- Secondary forms of dystonia, including tardive dyskinesia

- History of seizure disorder

- Symptoms of a clinically relevant illness in the 2 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications, anti-seizure medications, anticholinergic drugs, and muscle relaxants

- Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines

- History of neuroleptic medications

- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye

- Botulinum toxin injection within 3 months of starting the protocol

- Known hearing loss

Special Instructions:
Currently Not Provided
Keywords:
Cerebellum
Transcranial Magnetic Stimulation (TMS)
Blepharospasm
DYT-1 Generalized Dystonia
Focal Dystonia
Recruitment Keyword(s):
Dystonia
Focal Dystonia
Healthy Volunteer
HV
Condition(s):
Dystonia
Focal Dystonia
Cerebellar Disease
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Sole J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433 44. Review.

Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. No abstract available.

Aramideh M, Ongerboer de Visser BW, Holstege G, Majoie CB, Speelman JD. Blepharospasm in association with a lower pontine lesion. Neurology. 1996 Feb;46(2):476-8.

Active Accrual, Protocols Recruiting New Patients

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